Amitriptyline Hydrochloride
- Product NDC
- 68071-3656
- 11-digit product format
- 680713656
- Labeler code
- 68071
- Product ID
- 68071-3656_1e78bc61-52f7-5a4c-e063-6394a90ab181
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amitriptyline Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals, Inc.
- Application
- ANDA217411
- Marketing category
- ANDA
- Marketing start
- 2023-06-10
- Substance
- AMITRIPTYLINE HYDROCHLORIDE
- Active strength
- 25 mg/1
- Pharmacologic classes
- Tricyclic Antidepressant [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Amitriptyline Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AMITRIPTYLINE HYDROCHLORIDE | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 26LUD4JO9K |
| Rxcui | 856834 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68071-3656-3 | Amitriptyline Hydrochloride | 30 in 1 BOTTLE | TABLET | 30 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-3656 | AMITRIPTYLINE HYDROCHLORIDE TABLET [NUCARE PHARMACEUTICALS, INC.] | 1 | Current NDC, 1 package rows | 20240731_1e78e304-00e8-7cb3-e063-6294a90a87ad.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68071-3656-3 | 68071365603 | 30 TABLET in 1 BOTTLE (68071-3656-3) | 30 tablet | 2024-07-30 | No | No | Current |